Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Notices 77321 

appropriate component office of the 

Commission. 

The FMC will implement a new web 

portal, the FMC Assistance Center, 

available through the agency’s website 

to collect this information from the 

public. The collected information will 

be internally routed to the appropriate 

component office for response. As this 

collection includes inquiries related to 

dispute resolution services, it also 

encompasses Forms FMC–32 (Dispute 

Resolution Service Request—Cruise) 

and FMC–33 (Dispute Resolution 

Service Request—Cargo). Forms FMC– 

32 and FMC 33 have been modified in 

the Affirmation section to remove a 

statement directing the public to a link 

on the agency web page and to add a 

statement that the matter will be closed 

if false statements and documents are 

provided. These forms and the 

Assistance Center screen mock-ups are 

included in this docket. The burden 

associated with these forms is included 

in this collection. 

Current Actions: The information 

being submitted contains a new data 

collection. 

Type of Review: New information 

collection. 

Needs and Uses: The Commission 

will use the FMC Assistance Center 

(web portal) to receive requests from the 

public and ensure prompt response to 

the shipping public. 

Frequency: This information will be 

collected when members of the public 

choose to submit it. 

Type of Respondents: Individuals and 

establishments who wish to ask 

questions, express concerns, or submit 

complaints to the Federal Maritime 

Commission. 

Number of Annual Respondents: The 

Commission estimates an annual 

respondent universe of 5,000. The 

Commission further estimates 300 of 

these responses will require attaching 

an FMC form related to dispute 

resolution services (FMC–32 or FMC– 

33). 

Estimated Time per Response: The 

time per response is estimated at 6 

minutes per response for submissions 

that do not involve attaching forms and 

20 minutes for responses requiring 

attaching forms. 

Total Annual Burden: Burden is 

calculated as 4,700 × 6 minutes = 470 

hours per portal submission that does 

not also include a form and 300 × 20 

minutes = 100 hours for a submission 

that also includes either FMC–32 or 

FMC–33. Total burden equals 570 

hours. 

Carl Savoy, 

Federal Register Alternate Liaison Officer. 

[FR Doc. 2023–24785 Filed 11–8–23; 8:45 am] 

BILLING CODE 6730–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS 3452–PN] 

Medicare Program; Application by the 

Utilization Review Accreditation 

Commission (URAC) for Continued 

CMS Approval of Its Home Infusion 

Therapy (HIT) Accreditation Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Health and 

Human Services (HHS). 

ACTION: Notice with request for 

comment. 

SUMMARY: This notice acknowledges the 

receipt of an application from the 

Utilization Review Accreditation 

Commission (URAC) for continued 

approval by the Centers for Medicare & 

Medicaid Services (CMS) of URAC’s 

national accrediting organization 

program for suppliers providing home 

infusion therapy (HIT) services and that 

wish to participate in the Medicare or 

Medicaid programs. The statute requires 

that within 60 days of receipt of an 

organization’s complete application, 

CMS will publish a notice that identifies 

the national accrediting body making 

the request, describes the nature of the 

request, and provides at least a 30-day 

public comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, by 

December 11, 2023. 

ADDRESSES: In commenting, refer to file 

code CMS–3452–PN. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3452–PN, P.O. Box 8016, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3452–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Freeland, (410) 786–4348. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. We will not post on 

Regulations.gov public comments that 

make threats to individuals or 

institutions or suggest that the 

individual will take actions to harm the 

individual. We continue to encourage 

individuals not to submit duplicative 

comments. We will post acceptable 

comments from multiple unique 

commenters even if the content is 

identical or nearly identical to other 

comments. 

I. Background 

Home infusion therapy (HIT) is a 

treatment option for Medicare 

beneficiaries with a wide range of acute 

and chronic conditions. Section 5012 of 

the 21st Century Cures Act (Pub. L. 114– 

255, enacted December 13, 2016) added 

section 1861(iii) to the Social Security 

Act (the Act), establishing a new 

Medicare benefit for HIT services. 

Section 1861(iii)(1) of the Act defines 

‘‘home infusion therapy’’ as professional 

services, including nursing services; 

training and education not otherwise 

covered under the Durable Medical 

Equipment (DME) benefit; remote 

monitoring; and other monitoring 

services. HIT must be furnished by a 

qualified HIT supplier and furnished in 

the individual’s home. The individual 

must: 

• Be under the care of an applicable 

provider (that is, physician, nurse 

practitioner, or physician assistant); and 

• Have a plan of care established and 

periodically reviewed by a physician in 


ddrumheller on DSK120RN23PROD with NOTICES1
77322 Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Notices 

coordination with the furnishing of 

home infusion drugs under Part B, that 

prescribes the type, amount, and 

duration of infusion therapy services 

that are to be furnished. 

Section 1861(iii)(3)(D)(i)(III) of the Act 

requires that a qualified HIT supplier be 

accredited by an accrediting 

organization (AO) designated by the 

Secretary in accordance with section 

1834(u)(5) of the Act. Section 

1834(u)(5)(A) of the Act identifies 

factors for designating AOs and in 

reviewing and modifying the list of 

designated AOs. These statutory factors 

are as follows: 

• The ability of the organization to 

conduct timely reviews of accreditation 

applications. 

• The ability of the organization to 

take into account the capacities of 

suppliers located in a rural area (as 

defined in section 1886(d)(2)(D) of the 

Act). 

• Whether the organization has 

established reasonable fees to be 

charged to suppliers applying for 

accreditation. 

• Such other factors as the Secretary 

determines appropriate. 

Section 1834(u)(5)(B) of the Act 

requires the Secretary to designate AOs 

to accredit HIT suppliers furnishing HIT 

not later than January 1, 2021. Section 

1861(iii)(3)(D)(i)(III) of the Act requires 

a ‘‘qualified home infusion therapy 

supplier’’ to be accredited by a CMSapproved AO, pursuant to section 

1834(u)(5) of the Act. 

On March 1, 2019, we published a 

solicitation notice entitled, ‘‘Medicare 

Program; Solicitation of Independent 

Accrediting Organizations to Participate 

in the Home Infusion Therapy Supplier 

Accreditation Program’’ (84 FR 7057). 

This notice informed national AOs that 

accredit HIT suppliers of an opportunity 

to submit applications to participate in 

the HIT supplier accreditation program. 

We stated that complete applications 

would be considered for the January 1, 

2021, designation deadline if received 

by February 1, 2020. Regulations for the 

approval and oversight of AOs for HIT 

organizations are located at 42 CFR part 

488, subpart L. The requirements for 

HIT suppliers are located at 42 CFR part 

486, subpart I. 

II. Approval of Deeming Organization 

Section 1834(u)(5) of the Act and 

regulations at 42 CFR 488.1010 require 

that our findings concerning review and 

approval of a national accrediting 

organization’s requirements consider, 

among other factors, the applying 

accrediting organization’s requirements 

for accreditation; survey procedures; 

resources for conducting required 

surveys; capacity to furnish information 

for use in enforcement activities; 

monitoring procedures for provider 

entities found not in compliance with 

the conditions or requirements; and 

ability to provide CMS with the 

necessary data. 

Our rules at 42 CFR 488.1020(a) 

require that we publish, after receipt of 

an organization’s complete application, 

a notice that identifies the national 

accrediting body making the request, 

describes the nature of the request, and 

provides at least a 30-day public 

comment period. Pursuant to our rules 

at 42 CFR 488.1010(d), we have 210 

days from the receipt of a complete 

application to publish notice of 

approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of the Utilization 

Review Accreditation Commission 

(URAC) request for CMS’ continued 

recognition of its HIT accreditation 

program. This notice also solicits public 

comment on whether URAC’s 

requirements meet or exceed the 

Medicare requirements of participation 

for HIT services. 

III. Evaluation of Deeming Authority 

Request 

In the October 24, 2019, Federal 

Register, we published URAC’s initial 

application for recognition as an 

accreditation organization for HIT (84 

FR 57021). On April 1, 2020, we 

published notification of their approval 

as such an organization, effective March 

27, 2020, through March 27, 2024 (84 

FR 18243). URAC has since submitted 

all the necessary materials to enable us 

to make a determination concerning its 

request for continued recognition of its 

HIT accreditation program. This 

application was determined to be 

complete on August 30, 2023. Under 

section 1834(u)(5) of the Act and 42 CFR 

488.1010 (Application and reapplication procedures for national 

home infusion therapy accrediting 

organizations), our review and 

evaluation of URAC will be conducted 

in accordance with, but not necessarily 

limited to, the following factors: 

• The equivalency of URAC’s 

standards for HIT as compared with 

CMS’ HIT requirements for participation 

in the Medicare program. 

• URAC’s survey process to 

determine the following: 

++ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ The comparability of URAC’s to 

CMS’ standards and processes, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

++ URAC’s processes and procedures 

for monitoring a HIT found out of 

compliance with URAC’s program 

requirements. 

++ URAC’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ URAC’s capacity to provide CMS 

with electronic data and reports 

necessary for effective assessment and 

interpretation of the organization’s 

survey process. 

++ The adequacy of URAC’s staff and 

other resources, and its financial 

viability. 

++ URAC’s capacity to adequately 

fund required surveys. 

++ URAC’s policies with respect to 

whether surveys are announced or 

unannounced, to ensure that surveys are 

unannounced. 

++ URAC’s agreement to provide CMS 

with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as CMS may require (including 

corrective action plans). 

++ URAC’s policies and procedures to 

avoid conflicts of interest, including the 

appearance of conflicts of interest, 

involving individuals who conduct 

surveys, audits or participate in 

accreditation decisions. 

++ URAC’s agreement or policies for 

voluntary and involuntary termination 

of HIT suppliers. 

++ URAC’s agreement or policies for 

voluntary and involuntary termination 

of the HIT AO program. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping, or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

V. Response to Comments 

Because of the large number of public 

comments, we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble and when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Notices 77323 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Chyana Woodyard, who is 

the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Chyana Woodyard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–24850 Filed 11–8–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–1716] 

Compliance Policy for Cosmetic 

Product Facility Registration and 

Cosmetic Product Listing; Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a final 

guidance for industry and the public on 

the requirements related to cosmetic 

product facility registration and 

cosmetic product listing under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) entitled ‘‘Compliance Policy 

for Cosmetic Product Facility 

Registration and Cosmetic Product 

Listing.’’ This guidance announces 

FDA’s intention to delay enforcement of 

the requirements related to cosmetic 

product facility registration and 

cosmetic product listing for an 

additional 6 months after the initial 

December 29, 2023, deadline. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 9, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–D–1716 for ‘‘Compliance Policy 

for Cosmetic Product Facility 

Registration and Cosmetic Product 

Listing; Guidance for Industry; 

Availability.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Office of 

Cosmetics and Colors, Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Ross, Office of the Chief 

Scientist, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4332, Silver Spring, 

MD 20993–0002, 301–796–4880 (this is 

not a toll-free number), email: 

QuestionsAboutMoCRA@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry and the public 

entitled ‘‘Compliance Policy for 

Cosmetic Product Facility Registration 

and Cosmetic Product Listing.’’ This 

guidance is intended to assist owners or 

operators of cosmetic product facilities 

that are subject to the requirements 

related to facility registration and 

responsible persons that are subject to 

the requirements related to cosmetic 

product listing under the FD&C Act. We 

are issuing this guidance consistent 

with our good guidance practices (GGP) 

regulation (§ 10.115 (21 CFR 10.115)). 

We are implementing this guidance 

without prior public comment because 

we have determined that prior public 


ddrumheller on DSK120RN23PROD with NOTICES1